JP4953018B2 - Drug transfer device - Google Patents

Drug transfer device Download PDF

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JP4953018B2
JP4953018B2 JP2007508170A JP2007508170A JP4953018B2 JP 4953018 B2 JP4953018 B2 JP 4953018B2 JP 2007508170 A JP2007508170 A JP 2007508170A JP 2007508170 A JP2007508170 A JP 2007508170A JP 4953018 B2 JP4953018 B2 JP 4953018B2
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needle
main body
cylindrical
drug
medicine
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JPWO2006098345A1 (en
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馨 清水
康宏 村松
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Ajinomoto Co Inc
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Ajinomoto Co Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2051Connecting means having tap means, e.g. tap means activated by sliding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1475Inlet or outlet ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Description

この発明は薬剤移送具に関するものであり、輸液において点滴バッグ等の薬剤バッグへの薬剤の追加(混注)等の薬剤の移送作業に好適なものである。   The present invention relates to a medicine transfer device, and is suitable for a medicine transfer operation such as addition (mixed injection) of a medicine to a medicine bag such as an infusion bag in infusion.

点滴等の輸液に際して、ブドウ糖液や生理食塩水などの薬剤(第1の薬剤)が収容される薬剤バッグ(第1の薬剤収容体)にビタミン剤などの別の薬剤(第2の薬剤)の注入(混注)が必要な場合がある。点滴用の薬剤バッグはポリエチレンなどの可撓性フィルムにて袋状体に成形され、薬剤を収容した袋状体をゴムなどの弾性素材にて形成された栓(第1のゴム栓)を備えた排出口により封止して構成される。他方、薬剤バッグへ混注すべき薬剤の混注容器(第2の薬剤収容体)は剛性のあるプラスチック成形体として構成されると共に針状の注入口(混注口)を封止するゴム栓(第2のゴム栓)を備え、第2のゴム栓を開封しつつ第2の薬剤収容体の針状注入口にて第1の薬剤収容体のゴム栓を穿刺し、第2の薬剤収容体中の第2の薬剤を針状注入口を介して第1の薬剤収容体に移送(混注)している。この種の移送方式として、第2の薬剤収容体(混注容器)の針状注入口の本体(筒状部)を相対移動可能とし、混注のため第2の薬剤収容体(混注容器)の針状注入口を第1の薬剤収容体を封止する第1のゴム栓に穿刺する際に、第2の薬剤収容体を封止する第2のゴム栓を開封させ、混注操作を行わしめるものが提案されている(特許文献1)。
特公平6−59302号公報
In the case of infusion such as drip, another drug (second drug) such as a vitamin drug is stored in a drug bag (first drug container) in which a drug (first drug) such as glucose solution or physiological saline is stored. Injection (mixed injection) may be required. The infusion drug bag is formed into a bag-like body with a flexible film such as polyethylene, and includes a plug (first rubber stopper) formed of an elastic material such as rubber. It is configured to be sealed by an exhaust port. On the other hand, a mixed injection container (second drug container) for a drug to be mixed into a drug bag is configured as a rigid plastic molded body and has a rubber plug (second injection port) for sealing a needle-like injection port (mixed injection port). The rubber plug of the first drug container is punctured at the needle-like injection port of the second drug container while opening the second rubber plug, The second medicine is transferred (mixed injection) to the first medicine container through the needle-like injection port. As a transfer method of this type, the main body (cylindrical portion) of the needle-like inlet of the second drug container (mixed injection container) can be moved relative to the needle of the second drug container (mixed container) for mixed injection. The second rubber plug for sealing the second drug container is opened and the mixed injection operation is performed when puncturing the first injection hole into the first rubber plug for sealing the first drug container Has been proposed (Patent Document 1).
Japanese Examined Patent Publication No. 6-59302

従来技術では混注容器(第2の薬剤収容体)はゴム栓(第2のゴム栓)により封止され、混注容器の針状混注口により第1の薬剤収容体のゴム栓(第1のゴム栓)を穿刺する際に、針状混注口の本体の相対移動を惹起させ、この相対移動により第2のゴム栓を開封し、混注容器中の第2の薬剤の、第1の薬剤収容体への移送(混注)を行うようにしている。そのため、従来技術では混注容器を封止する別体の第2のゴム栓は混注容器に対して圧嵌し、混注作業時に惹起される相対移動により第2のゴム栓を離脱させて開封している。ゴム栓の圧嵌構造であるため、構造として複雑であり、部品点数も増えるためコストが嵩んでしまう問題点がある。また、開封時に栓体が完全離脱され混注容器中を落下してしまう恐れがあり、これを回避するためゴム栓を可撓性部材により懸架する構造も提案されているが、これは構造を一層複雑化せしめる。   In the prior art, the mixed injection container (second drug container) is sealed by a rubber plug (second rubber plug), and the rubber plug (first rubber container) of the first drug container is formed by the needle-shaped mixed injection port of the mixed injection container. When the stopper is punctured, a relative movement of the main body of the needle-like mixed injection port is caused, the second rubber stopper is opened by this relative movement, and the first drug container of the second drug in the mixed injection container is opened. (Mixed injection) is performed. Therefore, in the prior art, a separate second rubber stopper that seals the mixed injection container is press-fitted to the mixed injection container, and the second rubber stopper is detached and opened by relative movement caused during the mixed injection operation. Yes. Since the rubber plug has a press-fitting structure, the structure is complicated, and the number of parts increases, which increases the cost. In addition, there is a possibility that the plug body may be completely detached at the time of opening and fall in the mixed injection container. To avoid this, a structure in which a rubber plug is suspended by a flexible member has been proposed. Make it complicated.

この発明は以上の問題点に鑑みてなされたものであり、部品点数を増加させることなく確実な密封を維持しつつ、移送(混注)時の確実な開封を確保しうる構造を提供することを目的とする。   The present invention has been made in view of the above problems, and provides a structure capable of ensuring a reliable opening during transfer (mixed injection) while maintaining a reliable seal without increasing the number of parts. Objective.

請求項1に記載の発明によれば、点滴バッグに軟質容器からの薬剤を移送するための薬剤移送具であって、軟質容器に連結され、軟質容器からの薬剤を受容すべき第1の筒状本体と第1の筒状本体から離間側に薬剤の排出のための針状部を形成した第2の筒状本体とを具備して成り、針状部は点滴バッグを封止する弾性材製の栓体の穿刺を行うものであり、前記第1の筒状本体は第2の筒状本体に対し相対摺動可能に挿入され、第1及び第2の筒状本体は摺動方向において対向する第1及び第2の端面を夫々形成しており、第1の筒状本体の前記第1の端面は第2の筒状本体の前記第2の端面に向けて片持状に突出する突起部を備え、かつこの突起部は前記第1の端面に対して脆弱部を介して連結されており、第2の筒状本体の第2の端面は第1の筒状本体の第1の端面における前記突起部を収容するための凹部を形成しており、更に、第1及び第2の筒状本体は摺動時における回転方向の位置決めのための位置決め手段を具備しており、軟質容器からの薬剤は通常は前記第1の筒状本体内において封止状態にあるが、第1及び第2の筒状本体の相対摺動により突起部が前記凹部に収容され、前記第1及び第2の端面の当接により第2の端面に当接する第1の端面の部位が少なくとも部分的に破損されて、第1の筒状本体における薬剤の前記封止状態が解除され、軟質容器の薬剤は前記針状部を介して点滴バッグ中の薬剤に混注のための薬剤の移送が可能となるようにされることを特徴とする薬剤移送具が提供される According to invention of Claim 1, it is a chemical | medical agent transfer tool for transferring the chemical | medical agent from a soft container to an infusion bag, Comprising : The 1st pipe | tube connected with a soft container and which should receive the chemical | medical agent from a soft container And a second cylindrical main body formed with a needle-shaped portion for discharging the drug on the side away from the first cylindrical main body, and the needle-shaped portion is an elasticity for sealing the drip bag The first tubular body is inserted so as to be slidable relative to the second tubular body, and the first and second tubular bodies are slidable in the sliding direction. And the first end surface of the first cylindrical body protrudes in a cantilevered manner toward the second end surface of the second cylindrical body. And a projection that is connected to the first end surface via a fragile portion, and the second end surface of the second cylindrical body. A recess is formed in the first end face of the first cylindrical body to accommodate the protrusion, and the first and second cylindrical bodies are for positioning in the rotational direction during sliding. and comprises a positioning means, but the drug from the flexible container is usually located in the sealed state in said first tubular body, projections Ri by the relative sliding movement of the first and second tubular body Is housed in the recess, and the first end surface portion that contacts the second end surface is at least partially damaged by the contact of the first and second end surfaces, so that the drug in the first cylindrical body is A medicine transporting device characterized in that the sealed state is released, and the medicine in the soft container can be transported to the medicine in the infusion bag via the needle-like portion for the purpose of mixed injection. Provided .

請求項に記載の発明によれば、請求項に記載の発明において、第1の筒状本体と第2の筒状本体との摺動抵抗は前記針状部による前記栓体の穿刺抵抗より大きいことを特徴とする薬剤移送具が提供される。 According to the invention described in claim 2 , in the invention described in claim 1 , the sliding resistance between the first cylindrical body and the second cylindrical body is the puncture resistance of the plug body by the needle-like portion. A drug delivery device characterized in that it is larger is provided.

請求項に記載の発明によれば、請求項に記載の発明において、折損による封止状態の解除に至るまでの第1及び第2の筒状本体間の相対摺動操作の完了を確認せしめるための確認手段を更に具備したことを特徴とする薬剤移送具が提供される。
According to the invention described in claim 3 , in the invention described in claim 1, it is confirmed that the relative sliding operation between the first and second cylindrical bodies has been completed until the sealed state is released due to breakage. There is provided a medicine transporting device characterized by further comprising confirmation means for caulking.

請求項1の発明の作用・効果を説明すると、第2の筒状本体の針状部を点滴バッグの栓体に穿刺しつつ第1及び第2の筒状本体を対向端面の当接による部分的破損に至るまで相対摺動させることで、第2の筒状本体に対向した第1の筒状本体を少なくとも部分的に破損に至らせ、第1の筒状本体における薬剤の封止状態を解除し、薬剤を点滴バッグの栓体に穿刺された針状部を介して、点滴バッグに移送している。そのため、点滴バッグへの薬剤の混注を確実に行うことができ、しかも部分的な破損により封止状態を解除するものであるため、薬剤移送具の部品点数の削減及び構造の単純化によるコスト減を実現することができるThe operation and effect of the invention of claim 1 will be described. The first and second tubular bodies are brought into contact with the opposing end surfaces while the needle-like portion of the second tubular body is pierced into the stopper of the drip bag. The first cylindrical body opposed to the second cylindrical body is at least partially damaged by relative sliding until a mechanical damage is reached, and the sealed state of the drug in the first cylindrical body is changed. The drug is released and transferred to the infusion bag via the needle-like portion pierced into the stopper of the infusion bag. As a result, it is possible to reliably mix the medicine into the infusion bag, and to release the sealed state due to partial breakage, thus reducing the number of parts of the medicine transfer tool and reducing the cost by simplifying the structure. Can be realized .

分的破損部位を一体脆弱部とすることにより一層の低コストを実現しつつ確実な開封動作を確保することができる。 It is possible to ensure reliable opening operation while realizing further cost by integral fragile part part partial breakage sites.

第1及び第2の筒状本体の対向端面の当接による部分的破損により閉鎖状態の解除を一層確実かつ簡単に行うことができ、部品点数の削減及び構造の単純化によるコスト減を実現することができる。
封時の破損部位を相手側面に向けて突出する突起部とすることにより、開封時に突起部に曲げ力が加わり、根元を破損させることで、開封を確実に起こさせることができる。
一体成形の突起部の連結を脆弱部によって行うことにより、成形の容易に行うことができると共に、開封時の確実な折損も確保することができる。
折損後の突起部を凹部に収容させることができ、混注を効率的に行うことができ、折損された突起部が内部を浮遊することがない。
位置決め手段を設けることにより開封時のための突起部と凹部との確実な嵌合を行わせることができる。
The closed state can be more reliably and easily released due to partial breakage caused by contact of the opposing end surfaces of the first and second cylindrical main bodies, and the number of parts can be reduced and the cost can be reduced by simplifying the structure. be able to.
The broken portion during opening sealed by the protruding portion protruding toward the mating side, bending force is applied to the protrusion upon opening, by damaging the roots can be reliably cause opening.
By connecting the integrally formed protrusions with the weakened portion, the forming can be easily performed, and a reliable breakage at the time of opening can be ensured.
The broken protrusions can be accommodated in the recesses, so that mixed injection can be performed efficiently, and the broken protrusions do not float inside.
By providing the positioning means, it is possible to perform reliable fitting between the projection and the recess for opening.

請求項の発明の作用・効果を説明すると、針状部を点滴バッグの栓体に完全に穿刺後に第1の筒状本体と第2の筒状本体との相対摺動による薬剤の封止状態の解除が行われるため、混注操作の過程において、薬剤を外部に漏洩せしめることなく作業を行うことができる。 The action and effect of the invention of claim 2 will be described. After completely puncturing the needle-like portion into the stopper of the drip bag , the medicine is sealed by relative sliding between the first cylindrical body and the second cylindrical body. Since the state is released, the work can be performed without leaking the medicine to the outside in the course of the mixed injection operation.

請求項の発明の作用・効果を説明すると、折損による封止状態の解除を確認せしめるための確認手段を設けることで、混注作業を誤動作なく誰でも確実に行わせることができる。確認手段としてはクリック音などの聴覚による手段や識別マークや文字等の視覚的手段などにより構成することができる。 The operation and effect of the invention of claim 3 will be described. By providing a confirmation means for confirming the release of the sealed state due to breakage, anyone can reliably perform mixed injection work without malfunction. The confirmation means can be constituted by an auditory means such as a click sound or a visual means such as an identification mark or a character.

図1は組み立て前におけるポート本体と針状本体とを一部断面にて示す平面図(図2のI−I線にて表される矢視図)である。FIG. 1 is a plan view (a view taken in the direction of the arrow I-I in FIG. 2) showing a partial cross section of a port body and a needle-shaped body before assembly. 図2は図1と同様であるが、一部断面にて表した側面図である(図1のII−II線にて表される矢視図)である。FIG. 2 is the same as FIG. 1 but is a side view (part view taken along the line II-II in FIG. 1) showing a partial cross section. 図3は軟質容器装着部から離間側におけるポート本体の端面図(図1のIII−III線に沿う矢視図)である。FIG. 3 is an end view of the port body on the side away from the soft container mounting portion (a view taken along the line III-III in FIG. 1). 図4はポート本体と針状本体との嵌合部の横断面図(図6のIV−IV線に沿う矢視断面図)である。4 is a cross-sectional view (a cross-sectional view taken along the line IV-IV in FIG. 6) of the fitting portion between the port main body and the needle-shaped main body. 図5は針状本体の断面図(図1のV−V線に沿う矢視断面図)である。FIG. 5 is a cross-sectional view of the needle-like body (a cross-sectional view taken along the line VV in FIG. 1). 図6は組み立て状態(未開封時)における混注容器組立体の一部断面にて示す平面図(図7のVI−VI線にて表される矢視図)である。FIG. 6 is a plan view (a view taken along the line VI-VI in FIG. 7) showing a partial cross section of the mixed injection container assembly in an assembled state (when unopened). 図7は組み立て状態(未開封時)における混注容器組立体の一部断面にて表した側面図である(図6のVII−VII線にて表される矢視図)である。FIG. 7 is a side view (partial view taken along line VII-VII in FIG. 6) showing a partial cross section of the co-injection container assembly in an assembled state (when unopened). 図8は混注時における混注容器組立体を、その一部を断面にて示す平面図である。FIG. 8 is a plan view showing a part of a mixed injection container assembly at the time of mixed injection in cross section. 図9は突起の一致による開通確認手段を備えた混注容器の部分破断平面図であり、(イ)は未開通時、(ロ)は開通時を示す。FIG. 9 is a partially broken plan view of a co-injection container provided with means for confirming opening by matching of protrusions. (A) shows an unopened state and (B) shows an opened state. 図10は透明部の一致による開通確認手段を備えた混注容器の部分破断平面図であり、(イ)は未開通時、(ロ)は開通時を示す。FIG. 10 is a partially broken plan view of a mixed injection container provided with a means for confirming opening by matching the transparent portions. (A) shows an unopened state and (B) shows an opened state. 図11は指標部の閉鎖による開通確認手段を備えた混注容器の部分破断平面図であり、(イ)は未開通時、(ロ)は開通時を示す。FIG. 11 is a partially broken plan view of a mixed injection container provided with an opening confirmation means by closing an indicator portion, where (a) shows an unopened state and (b) shows an opened state. 図12は刻印一致型の開通確認手段を備えた混注容器の部分破断平面図であり、(イ)は未開通時、(ロ)は開通時を示す。FIGS. 12A and 12B are partially broken plan views of a mixed injection container provided with engraving type opening confirmation means. FIG. 12A shows an unopened state and FIG. 12B shows a opened state.

符号の説明Explanation of symbols

10 ポート本体(本発明の第1の筒状本体)
11 針状本体(本発明の第2の筒状本体)
12 ポート本体の中心通路
20 脆弱突起部
30 位置決めリブ
40 針状本体の中心通路
42 針状部
46 側方孔
50 脆弱突起収容溝(本発明の凹部)
60 U状ガイド
62 ガイド溝
80 軟質容器
84 軟質容器の薬剤収容空洞部
90 点滴バッグ
94 点滴バッグ空洞部
96 点滴バッグポート部材
10 port body (first cylindrical body of the present invention)
11 Needle-shaped body (second cylindrical body of the present invention)
12 Port body center passage 20 Weak protrusion 30 Positioning rib 40 Needle body center passage 42 Needle portion 46 Side hole 50 Weak protrusion receiving groove (concave portion of the present invention)
60 U-shaped guide 62 Guide groove 80 Soft container 84 Drug container cavity 90 of soft container Infusion bag 94 Infusion bag cavity 96 Infusion bag port member

この発明の薬剤移送具の実施形態を説明すると、この実施形態の薬剤注入具はブドウ糖液や生理食塩水などの薬剤(第1の薬剤)が収容される輸液バッグ(第1の薬剤収容体)にビタミン剤などの別の薬剤(第2の薬剤)の注入(混注)を行うためのものである。図1及び図2において薬剤注入具はポート本体10(この発明の第1の筒状本体)と針状本体11(この発明の第2の筒状本体)とを具備する。ポート本体10は、後述のように、混注すべき第2の薬剤を収容するためのプラスチックフィルム製軟質容器(第2の薬剤収容体)に連結される。針状本体11は、後述のように、その針状部が輸液バッグのゴム栓に穿刺され、プラスチックフィルム製軟質容器に収容された薬剤が輸液バッグに移送(混注)される。 An embodiment of the drug delivery device of the present invention will be described. The drug injection device of this embodiment is an infusion bag (first drug container) in which a drug (first drug) such as glucose solution or physiological saline is stored. This is for injecting (mixed injection) another medicine (second medicine) such as a vitamin preparation. 1 and 2, the drug injection device includes a port main body 10 (first cylindrical main body of the present invention) and a needle-shaped main body 11 ( second cylindrical main body of the present invention). As will be described later, the port body 10 is connected to a plastic film soft container (second drug container) for storing the second drug to be mixed and injected. As will be described later, the needle-like main body 11 has a needle-like portion punctured by a rubber stopper of an infusion bag, and a medicine contained in a soft plastic film container is transferred (mixed injection) to the infusion bag.

図1及び図2において、ポート本体10はその形状を維持しうるに十分な剛性を有した硬質プラスチックにて形成するものが好ましく、プラスチックの材質としては、限定的ではないが、ABS(アクリロニトリル−スチレン−ブタジエン共重合体)、PP(ポリプロピレン樹脂)、PE(ポリエチレン樹脂)、硬質PVC(硬質塩化ビニル樹脂)、PC(ポリカーボネート樹脂)、COP(環状ポリオレフィン樹脂)、PS(ポリスチレン樹脂)、アクリル樹脂、PET(ポリエチレンテレフタレート樹脂)などをあげることができる。ポート本体10は全体として筒形状をなし、軸線方向に延びる中心流路12を形成している。中心流路12は、針状本体11から離間した一端12-1は幾分拡開しながら開口しており、針状本体11に近接した他端12-2は通常は閉鎖している。即ち、ポート本体10は針状本体11に対向した端面が直径線から下側の半分14は直立面をなしているが、直径線から上側が比較的肉の薄い傾斜面16によって針状本体11の側に向かって幾分の張出部10-1を形成し、最上部の直立面18に連なっている(図3も参照)。即ち、ポート本体10は針状本体11に対向した端面が3個の部分14, 16, 18により形成されるが、これらの部分14, 16, 18は、中心流路12の針状本体11側の全面に渡って連なっており、中心流路12を針状本体11の側において閉鎖している。   In FIGS. 1 and 2, the port body 10 is preferably formed of a hard plastic having sufficient rigidity to maintain its shape, and the material of the plastic is not limited to ABS (acrylonitrile- Styrene-butadiene copolymer), PP (polypropylene resin), PE (polyethylene resin), rigid PVC (hard vinyl chloride resin), PC (polycarbonate resin), COP (cyclic polyolefin resin), PS (polystyrene resin), acrylic resin And PET (polyethylene terephthalate resin). The port body 10 has a cylindrical shape as a whole, and forms a central flow path 12 extending in the axial direction. The central flow path 12 is opened while the one end 12-1 spaced from the needle-shaped body 11 is somewhat expanded, and the other end 12-2 adjacent to the needle-shaped body 11 is normally closed. In other words, the end surface of the port body 10 facing the needle-shaped body 11 has an upright surface on the lower half 14 from the diameter line, but the needle-shaped body 11 is formed by the relatively thin inclined surface 16 on the upper side from the diameter line. Some overhangs 10-1 are formed toward this side, and are connected to the uppermost upright surface 18 (see also FIG. 3). That is, the end face of the port body 10 facing the needle-like body 11 is formed by three portions 14, 16, and 18 that are formed on the side of the needle-like body 11 of the central flow path 12. The central channel 12 is closed on the side of the needle-shaped main body 11.

図3に示すように、傾斜面16から突起部20が一体に直交方向に延びており、傾斜面16の傾斜故に、図1において、突起部20はポート本体10の軸線に対して下向きをなし、かつポート本体10の最も針状本体11側の端面部分18を超えて延びている。そのため、後述のように、ポート本体10を針状本体11に嵌合した場合に、最初に突起部20が針状本体11の対向面に係合され、図1で下向きに曲げ付勢される。そして、突起部20の根元の傾斜面16は肉薄であるため、この根元の部分22が脆弱となっており、突起部20が針状本体11の対向面に係合された場合の下向き付勢力により突起部20は脆弱部22により少なくとも曲げ側で折損されるに至る。そのため、この折損部位において針状本体11側の端面における封止が破れ、中心流路12は針状本体11に対して開口せしめられる。傾斜面16における肉薄部は突起部20の根元の全周であっても、部分的であってもよく、また、突起部20の内部を空洞に形成することにより突起部20の側面全周の若しくは部分的な肉薄部に構成することもできる。更に、突起部20を破損し易くなるようにU字型などの切り込みを付与することによりに薄部に形成することも可能である。 As shown in FIG. 3, the protruding portion 20 integrally extends from the inclined surface 16 in the orthogonal direction. Due to the inclination of the inclined surface 16, the protruding portion 20 does not face downward with respect to the axis of the port body 10 in FIG. , And extends beyond the end face portion 18 of the port body 10 closest to the needle-like body 11. Therefore, as will be described later, when the port main body 10 is fitted to the needle-shaped main body 11, the protrusion 20 is first engaged with the opposing surface of the needle-shaped main body 11, and is bent and biased downward in FIG. . Since the base inclined surface 16 of the protrusion 20 is thin, the base portion 22 is fragile, and the downward biasing force when the protrusion 20 is engaged with the opposing surface of the needle-like body 11. As a result, the protrusion 20 is broken at least on the bending side by the fragile portion 22. Therefore, the sealing at the end surface on the side of the needle-shaped main body 11 is broken at the broken portion, and the central flow path 12 is opened to the needle-shaped main body 11. The thin portion of the inclined surface 16 may be the entire circumference of the base of the protrusion 20 or may be partial, and by forming the inside of the protrusion 20 in a cavity, the entire circumference of the side surface of the protrusion 20 is formed. Or it can also be comprised in a partial thin part. Furthermore, it is also possible to form the thin-walled portion so by applying the cut, such as U-shape so as to easily break the protrusion 20.

ポート本体10は外周において環状溝24を形成しており、この環状溝24にOリング26が嵌着され、Oリング26はポート本体10と針状本体11との挿入部のシールを行う。また、ポート本体10は外周における直径対立位置に、夫々が環状フランジ部28より長手方向に環状溝24の手前まで延びる位置決めリブ30(本発明の位置決め手段)を形成している。リブ30は、後述のように、ポート本体10と針状本体11との挿入合体時に針状本体11の位置決め溝に嵌合することにより、両部材10, 11の回転方向の位置決め(周り止め)を行う機能を達成する。リブ30は両側側面にロック用の突起32を形成している。   The port body 10 has an annular groove 24 formed on the outer periphery thereof, and an O-ring 26 is fitted into the annular groove 24, and the O-ring 26 seals the insertion portion between the port body 10 and the needle-like body 11. Further, the port body 10 is formed with positioning ribs 30 (positioning means of the present invention) that extend in the longitudinal direction from the annular flange portion 28 to the front of the annular groove 24 at the diameter opposite positions on the outer periphery. As will be described later, the rib 30 is fitted in the positioning groove of the needle-shaped main body 11 when the port main body 10 and the needle-shaped main body 11 are inserted together, thereby positioning the both members 10 and 11 in the rotational direction (rotation prevention). Achieve the function to do. The rib 30 has locking protrusions 32 on both side surfaces.

更に、ポート本体10は、中心流路12の開放端部12-1の側において扁平フランジ部34を形成しており、この扁平フランジ部34に、混注用薬剤を収容する軟質容器を形成するプラスチックフィルムが後述のように、熱圧着により封止される。   Further, the port body 10 has a flat flange portion 34 formed on the open end portion 12-1 side of the central flow path 12, and the flat flange portion 34 is a plastic forming a soft container for containing a mixed injection drug. The film is sealed by thermocompression as described below.

次に、針状本体11の構造について説明すると、針状本体11もポート本体10と同様にその形状を維持しうるに十分な剛性を有した硬質プラスチックにて形成するものが好ましく、プラスチックの材質としては、ポート本体10と同様に、限定的ではないが、ABS(アクリロニトリル−スチレン−ブタジエン共重合体)、PP(ポリプロピレン樹脂)、PE(ポリエチレン樹脂)、硬質PVC(硬質塩化ビニル樹脂)、PC(ポリカーボネート樹脂)、COP(環状ポリオレフィン樹脂)、PS(ポリスチレン樹脂)、アクリル樹脂、PET(ポリエチレンテレフタレート樹脂)などをあげることができる。針状本体11は全体として筒形状をなし、軸線方向に延びる中心流路40を有している。ポート本体10の側の一端40-1はストレートに開口しており、この開口部分に、後述のようにポート本体10の先端部分が嵌合装着される。針状本体11の中心流路40はその他端40-2が針状部42まで延びており、かつ針状部42において中心流路40-2は内径を絞られ、針状部42の先端先鋭部42-1の若干手前の部位において、中心流路40-2は側方孔46において外部に開口している。後述のように、混注時に混注容器からの薬剤は側方孔46より点滴バッグに移送混注される。   Next, the structure of the needle-shaped main body 11 will be described. The needle-shaped main body 11 is also preferably formed of a hard plastic having sufficient rigidity to maintain its shape, similar to the port main body 10. As in the case of the port body 10, there is no limitation, but ABS (acrylonitrile-styrene-butadiene copolymer), PP (polypropylene resin), PE (polyethylene resin), hard PVC (hard vinyl chloride resin), PC (Polycarbonate resin), COP (cyclic polyolefin resin), PS (polystyrene resin), acrylic resin, PET (polyethylene terephthalate resin), and the like. The needle-shaped main body 11 has a cylindrical shape as a whole and has a central flow path 40 extending in the axial direction. One end 40-1 on the side of the port main body 10 is opened straight, and the front end portion of the port main body 10 is fitted and attached to the opening as described later. The other end 40-2 of the central flow path 40 of the needle-shaped main body 11 extends to the needle-shaped portion 42, and the inner diameter of the central flow path 40-2 is reduced in the needle-shaped portion 42, and the tip of the needle-shaped portion 42 is sharpened. The central channel 40-2 is open to the outside through the side hole 46 at a position slightly before the portion 42-1. As will be described later, at the time of mixed injection, the medicine from the mixed injection container is transferred and mixed into the infusion bag from the side hole 46.

針状本体11の中心流路40のストレート孔部分は、中心流路40の長手方向中心線を挟んで、ストレート孔部分の底面40-3から幾分隆起した一対の部分48(図5参照)を形成しており、隆起部分48は90度で交差するエッジ48-1, 48-2で留まっており、隆起部分48の対向エッジ48-2間に直径方向の溝50(本発明の凹部)が形成され、直線上のエッジ48-1より底面40-3側は窪み51を呈している。この溝50の幅はポート本体10の突起部20の直径より幾分幅広となっており、混注操作のため、ポート本体10を針状本体11に深く押込操作した場合に、押込操作の最初の過程において突起部20を溝50に確実に収容することができ、限界まで押込むことにより突起部20が脆弱部22において折損した場合においては、突起部20を溝50内に完全に収容・保持することができ、デッドスペースを可及的に小さくし、混注容器の薬剤を無駄なく点滴バッグに移送することができるようになっている。

The straight hole portion of the central flow path 40 of the needle-shaped body 11 is a pair of portions 48 slightly raised from the bottom surface 40-3 of the straight hole portion with the longitudinal center line of the central flow path 40 interposed therebetween (see FIG. 5). The raised portion 48 remains at the edges 48-1 and 48-2 that intersect at 90 degrees, and the diametrical groove 50 (the recess of the present invention) between the opposed edges 48-2 of the raised portion 48. The bottom surface 40-3 side of the straight edge 48-1 has a depression 51. The width of the groove 50 is somewhat wider than the diameter of the protrusion 20 of the port body 10. When the port body 10 is pushed deeply into the needle-like body 11 for the mixed injection operation, the first pushing operation is performed. In the process, the protrusion 20 can be reliably accommodated in the groove 50, and when the protrusion 20 is broken at the fragile portion 22 by being pushed to the limit, the protrusion 20 is completely accommodated and held in the groove 50. The dead space can be made as small as possible, and the medicine in the mixed injection container can be transferred to the infusion bag without waste.

図1に示すように、針状本体11は針状部42に近接した外周面に環状溝54を形成しており、この環状溝54にはO−リング56が装着され、このO−リング56はニードルキャップ58(図6)を装着した場合の密封用である。また、針状本体11は針状部42から離間側の開放端面に近接した外周の直径対立位置に一対のU状ガイド60を有している。図2に示すように、各U状ガイド60はU字断面形状をなしており、ポート本体10に向けて開口したガイド溝62がU状ガイド60の内側に形成され、ガイド溝62にポート本体10のガイドリブ30を挿入することができる。図2に示すように、各ガイド溝62は、対向面の各々に2段のテーパ面62-1, 62-2と、夫々のテーパ面62-1, 62-2の端部の係止突起部62A, 62Bを備えている。後述の通り、係止突起部62A, 62Bにポート本体10側のガイドリブ30のロック用の突起32を選択的に係合させることにより、ポート本体10の、針状本体11に対する挿入深さを封止状態(組立て状態であるが未使用時)と押込状態(薬剤混注時)との2段階にロックすることができる。   As shown in FIG. 1, the needle-like main body 11 has an annular groove 54 formed on the outer peripheral surface close to the needle-like portion 42, and an O-ring 56 is attached to the annular groove 54. Is for sealing when the needle cap 58 (FIG. 6) is attached. Further, the needle-like main body 11 has a pair of U-shaped guides 60 at the outer diameter opposing positions near the open end surface on the side away from the needle-like portion 42. As shown in FIG. 2, each U-shaped guide 60 has a U-shaped cross-sectional shape, and a guide groove 62 that opens toward the port body 10 is formed inside the U-shaped guide 60. Ten guide ribs 30 can be inserted. As shown in FIG. 2, each guide groove 62 has two tapered surfaces 62-1 and 62-2 on each of the opposing surfaces, and locking protrusions at the ends of the respective tapered surfaces 62-1 and 62-2. The parts 62A and 62B are provided. As will be described later, by selectively engaging the locking protrusions 32A and 62B with the locking protrusion 32 of the guide rib 30 on the port body 10 side, the insertion depth of the port body 10 with respect to the needle-shaped body 11 is sealed. It can be locked in two stages: a stopped state (assembled state but not used) and a pushed-in state (during mixed medicine).

Oリング26, 56の材質としては、特に限定するものではないが、弾性体であることが好ましい。そのような弾性体としては、シリコンゴム、ブチルゴム、イソプレンゴム、天然ゴムなどのゴム製のものから、スチレン系エラストマー、オレフィン系エラストマー、ポリエステル系エラストマー、ナイロン系エラストマー等の高分子エラストマーを用いてもよい。   The material of the O-rings 26 and 56 is not particularly limited, but is preferably an elastic body. As such an elastic body, a polymer elastomer such as a styrene elastomer, an olefin elastomer, a polyester elastomer, or a nylon elastomer may be used from a rubber made of silicon rubber, butyl rubber, isoprene rubber, natural rubber or the like. Good.

次に、以上説明したこの発明の実施形態の薬剤注入具を点滴バッグに対する混注に使用する場合における使用態様を説明すると、ポート本体10と針状本体11との組立て状態は図6及び図7にて示され、ポート本体10はその閉鎖した先端部が針状本体11の後端側の開口部40-1に挿入される。この挿入の過程において、ポート本体10と針状本体11の回転方向の位置決め合わせは、ポート本体10の側の位置決めリブ30とポート本体10の側のガイド溝62とが芯合するように、かつ、針状本体11の張出部10-1が針状本体11の窪み部51と対向するようにされる。このような位置合わせ状態においてポート本体10を針状本体11に押し込むことにより、ポート本体10の側の位置決めリブ30は針状本体11の側のガイド溝62に挿入され、ポート本体10の、針状本体11に対する挿入を深めてゆくことにより、位置決めリブ30のロック用の突起32がガイド溝62の第1のテーパ面62-2を介して第1の係止突起部62Aを乗り越えた図7の状態が得られる。この状態では、位置決めリブ30のロック用の突起32は第2のテーパ面62-1の基部(窪みとなった部分)に係合する。そのため、ポート本体10と針状本体11とは図6及び図7に示す軸方向の位置関係(組立て状態)で弾性力下でロックされる。この組立て状態では、図6に示すように、ポート本体10の先端の脆弱突起20は針状本体11の筒状孔の対向底面40-3から離間して隆起部48間の溝を臨むように位置し、脆弱突起20はポート本体10の残余部位、即ち、肉薄傾斜面16(図3)との一体成形状態を維持する。そのため、ポート本体10の中心流路12は針状本体11側の端部12-2での閉鎖状態を維持する。そして、ニードルキャップ58が装着される。 Next, the usage mode in the case where the pharmaceutical injection device of the embodiment of the present invention described above is used for co-infusion with an infusion bag will be described. The assembled state of the port main body 10 and the needle-shaped main body 11 is shown in FIGS. The closed end of the port body 10 is inserted into the opening 40-1 on the rear end side of the needle-like body 11. In this insertion process, the positioning of the port body 10 and the needle-shaped body 11 in the rotational direction is performed so that the positioning rib 30 on the port body 10 side and the guide groove 62 on the port body 10 side are aligned with each other. The overhanging portion 10-1 of the needle-like main body 11 is made to face the hollow portion 51 of the needle-like main body 11. When the port body 10 is pushed into the needle-like body 11 in such an alignment state, the positioning rib 30 on the port body 10 side is inserted into the guide groove 62 on the needle-like body 11 side. By deepening the insertion into the main body 11, the locking protrusion 32 of the positioning rib 30 gets over the first locking protrusion 62A via the first tapered surface 62-2 of the guide groove 62. FIG. Is obtained. In this state, the locking protrusion 32 of the positioning rib 30 engages with the base portion (the recessed portion) of the second tapered surface 62-1. Therefore, the port main body 10 and the needle-shaped main body 11 are locked under elastic force in the axial positional relationship (assembled state) shown in FIGS. 6 and 7. In this assembled state, as shown in FIG. 6, the fragile protrusion 20 at the tip of the port body 10 is spaced from the opposed bottom surface 40-3 of the cylindrical hole of the needle-like body 11 so as to face the groove between the raised portions 48. The fragile protrusion 20 is located and remains in an integrally molded state with the remaining portion of the port body 10, that is, the thin inclined surface 16 (FIG. 3). Therefore, the center flow path 12 of the port body 10 maintains a closed state at the end 12-2 on the needle-like body 11 side. Then, a needle cap 58 is attached.

図6及び図7に示すポート本体10と針状本体11との組立状態において、混注用の軟質容器の形成及び薬剤の封入が行われる。即ち、プラスチックフィルムは上下二枚合わせられ、外周を熱圧着することで袋状(軟質容器)に形成される。このように形成された軟質容器80は図6において部分的に示され、軟質容器80は外周にシール部(プラスチックフィルムの熱圧着部)82を備えている。そして、軟質容器80は外周が部分的に未シールとされ開口するように形成され、この開口部にポート本体10の扁平フランジ部34を挿入位置させ、軟質容器80を形成するプラスチックフィルムを扁平フランジ部34の外周面に熱溶着することができる。この状態において、軟質容器80の空洞部84への薬剤の充填・封入が周知のように行われ、薬剤注入部、即ち、ポート本体10と針状本体11、を装着し、針状部42はニードルキャップ58を装着して成薬剤注入部と軟質容器との図6の如き混注容器組立体が完成する。

In the assembled state of the port main body 10 and the needle-shaped main body 11 shown in FIGS. 6 and 7, a soft container for co-infusion and formation of a medicine are performed. That is, the upper and lower plastic films are combined and formed into a bag shape (soft container) by thermocompression of the outer periphery. The soft container 80 formed in this way is partially shown in FIG. 6, and the soft container 80 includes a seal portion (thermocompression bonding portion of a plastic film) 82 on the outer periphery. The soft container 80 is formed so that the outer periphery is partially unsealed and opened, the flat flange portion 34 of the port body 10 is inserted into the opening, and the plastic film forming the soft container 80 is flattened with the flat flange. It can be thermally welded to the outer peripheral surface of the portion 34. In this state, the filling and sealing of the medicine into the hollow portion 84 of the soft container 80 is performed as is well known, and the medicine injection portion, that is, the port body 10 and the needle-like body 11 is mounted, and the needle-like portion 42 is such co-infusion container assembly of Figure 6 with the infusion part and the flexible container Ru formed by mounting the needle cap 58 is completed.

次に、図6の混注容器組立体による混注作業について説明すると、図8において点滴バッグ90は周知のように二枚重ねられたプラスチックフィルムの周辺部92を熱圧着して袋状に形成し、空洞部94にブドウ糖液や生理食塩水などの点滴用薬剤を収容し、熱圧着された周辺部92の所定箇所にポート部材96を固着して構成される。ポート部材96は筒状をなしたプラスチック材料の成形品であり、ポート部材96の外端部にはゴム等の弾性材料にて形成された栓98が装着されている。点滴バッグ90に軟質容器80中の薬剤を混注(移送)するため、混注容器組立体の押込により針状部42が点滴バッグ90のゴム栓98に対して穿刺される。ポート本体10と針状本体11との摺動抵抗は、針状部42がゴム栓98を穿刺するための抵抗力よりも大きくなるように設定されており、ポート本体10と針状本体11との嵌め合いや、針形状や、針表面加工等の各種の因子が調整される。そのため、図8に示すように針状部42がゴム栓98に深く穿刺されるに至るまで図6に示すようなポート本体10と針状本体11との相対位置(脆弱突起20が対向面40-3から離間した状態)は維持される。そのため、中心流路12の端部12-2の閉鎖状態、換言すれば、軟質容器80内での薬剤の封止状態は維持され、穿刺の途中において軟質容器80中の薬剤が漏出してしまうことはない。   Next, the mixed injection operation by the mixed injection container assembly of FIG. 6 will be described. In FIG. 8, the drip bag 90 is formed in a bag shape by thermocompression bonding of the peripheral portion 92 of the two plastic films stacked as is well known. 94, a drip medicine such as glucose solution or physiological saline is accommodated, and a port member 96 is fixed to a predetermined portion of the peripheral portion 92 which is thermocompression bonded. The port member 96 is a molded product made of a plastic material having a cylindrical shape, and a plug 98 made of an elastic material such as rubber is attached to the outer end portion of the port member 96. In order to infuse (transfer) the medicine in the soft container 80 into the infusion bag 90, the needle-like portion 42 is punctured into the rubber stopper 98 of the infusion bag 90 by pushing the infusion container assembly. The sliding resistance between the port main body 10 and the needle-shaped main body 11 is set so that the needle-shaped portion 42 is larger than the resistance force for puncturing the rubber plug 98. Various factors such as fitting, needle shape and needle surface processing are adjusted. Therefore, as shown in FIG. 8, the relative position of the port main body 10 and the needle-shaped main body 11 as shown in FIG. -3) is maintained. Therefore, the closed state of the end 12-2 of the central flow path 12, in other words, the sealed state of the medicine in the soft container 80 is maintained, and the medicine in the soft container 80 leaks out during puncturing. There is nothing.

針状部42が図8に示すようにゴム栓98に完全に穿刺された後も混注容器組立体を押し込み続けることにより、ポート本体10は針状本体11との摺動抵抗に打ち勝ち、針状本体11に対して相対摺動し、この摺動の過程において、ポート本体10の先端の突起20は隆起部分48間の溝50を介して針状本体11の対向面40-3に当接され、突起20には図6における下向き傾斜故に下向きの曲げ力が加わり、肉薄のため脆弱な根元の部分22にて折損される。折損は曲げ側では必ず起こるが反対側では一体を維持するものであっても、折損による開通機能には支障はない。ポート本体10と針状本体11とが対向面同士で当接するように完全に押し込まれた状態を図8にて示し、突起20は直立状態をとり、隆起部分48間の溝50に収容される。図8の完全押込位置では、図7におけるロック用の突起32がガイド溝62の第2のテーパ面62-2を介して第2の係止突起部62Bを乗り越えており、突起32, 62Bの係合により、ポート本体10と針状本体11との図8の相対位置(開封状態)は弾性力下で維持される。そして、突起20の折損によって図3の傾斜面16での密封は破られ、ポート本体10の中心流路12は、突起20の折損により傾斜面16に形成された開口部89を介して針状本体11の中心流路40, 40-2に連通せしめられる。そのため、軟質容器80内の薬剤は中心流路12, 12-2, 40, 40-2を介して側方孔46より点滴バッグ90の内部に移送せしめられる。   Even after the needle-like portion 42 is completely punctured into the rubber stopper 98 as shown in FIG. 8, the port body 10 overcomes the sliding resistance with the needle-like body 11 by continuing to push in the mixed injection container assembly. Relative sliding with respect to the main body 11, and in the course of this sliding, the projection 20 at the tip of the port main body 10 is brought into contact with the facing surface 40-3 of the needle-shaped main body 11 through the groove 50 between the raised portions 48. The protrusion 20 is applied with a downward bending force due to the downward inclination in FIG. 6 and is broken at the weak root portion 22 due to its thinness. Even if the breakage always occurs on the bending side, but the unit is maintained on the other side, there is no problem in the opening function due to the breakage. FIG. 8 shows a state in which the port body 10 and the needle-like body 11 are completely pushed so as to come into contact with each other between the opposing surfaces, and the protrusion 20 takes an upright state and is accommodated in the groove 50 between the raised portions 48. . 8, the locking projection 32 in FIG. 7 passes over the second locking projection 62B via the second tapered surface 62-2 of the guide groove 62, and the projections 32, 62B By the engagement, the relative position (opened state) of FIG. 8 between the port main body 10 and the needle-shaped main body 11 is maintained under elastic force. 3 is broken by the breakage of the protrusion 20, and the central flow path 12 of the port body 10 is needle-like through the opening 89 formed in the inclined surface 16 by the breakage of the protrusion 20. It is connected to the central flow paths 40, 40-2 of the main body 11. Therefore, the medicine in the soft container 80 is transferred into the drip bag 90 from the side hole 46 through the central flow paths 12, 12-2, 40 and 40-2.

以上の形態において、突起20が折損するまで押込が行われると、ロック用の突起32が2段目の係止突起部62B(図7)を乗り越え、この際カチッと音がするためこれが開通(封止状態の解除)に到るまでの押込操作が完了したことを作業者に確認せしめるための聴覚的な確認手段となる。これに加え、または、これとは別に未熟練のものにもの押込深さの確認において誤作業が生ずることがないように視覚的な確認手段を設けることができる。以上の実施形態においては、突起20の折損されるような押込時にポート本体10側の環状フランジ28と針状本体11側のガイドリブ30との隙間が丁度解消するようにすることができ、隙間=0を所定押込深さが得られたことの確認若しくは指標とすることができる。   In the above configuration, when the projection 20 is pushed until the projection 20 is broken, the locking projection 32 gets over the second-stage locking projection 62B (FIG. 7), and at this time, a clicking sound is generated. This is an audible confirmation means for confirming to the operator that the push-in operation up to the release of the sealed state has been completed. In addition to this, a visual confirmation means can be provided so that an unskilled one does not cause an erroneous operation in confirming the indentation depth. In the above embodiment, the gap between the annular flange 28 on the port main body 10 side and the guide rib 30 on the needle-shaped main body 11 side can be eliminated just when the projection 20 is pushed to break. 0 can be used as a confirmation or indicator that a predetermined indentation depth has been obtained.

図9は別実施形態における押込操作完了の確認手段を示しており、この実施形態では、ポート本体10のガイドリブ30に突部30A、針状本体11のU状ガイド60に突部60Aを設けることができる。突部30A, 60Bは図9(イ)に示す通常時(未開封時(突起20の未折損時))は離間しているが、開封時(突起20の折損時)は図9(ロ)に示すように突部30A, 60Bが整列するため、開封のためのポート本体10と針状本体11との押込深さの確認作業が容易かつ確実となる。   FIG. 9 shows a means for confirming the completion of the pushing operation in another embodiment. In this embodiment, a protrusion 30A is provided on the guide rib 30 of the port body 10, and a protrusion 60A is provided on the U-shaped guide 60 of the needle-like body 11. Can do. The protrusions 30A and 60B are separated in the normal state (when not opened (when the protrusion 20 is not broken)) shown in FIG. 9 (a), but when opened (when the protrusion 20 is broken), FIG. Since the protrusions 30A and 60B are aligned as shown in FIG. 4, the confirmation operation of the depth of pressing between the port main body 10 and the needle-shaped main body 11 for opening becomes easy and reliable.

図10は押込深さ確認手段の別実施形態を示しており、透明な合せ目を具備させた例である。即ち、ポート本体10は針状本体11に挿入される筒状部10´の円周方向の透明帯70を形成し、他方針状本体11はポート本体10の筒状部10´が挿入される筒状部11´に円周方向の透明帯72を有している。透明帯70, 72以外の部位ではポート本体10及び針状本体11は不透明となるように印刷やラベル貼着やしぼ加工(粗面加工)がされている。透明帯70, 72は図10(イ)に示す通常時(未開封時(突起20の未折損時))は離間し、重ならないため全体が透けないが、開封時(突起20の折損時)は図10(ロ)に示すように透明帯70, 72が重なるため全体が透けて見えることになり、これが所定深さの押し込みがなされたことの指標となる。   FIG. 10 shows another embodiment of the indentation depth confirmation means, which is an example in which a transparent seam is provided. That is, the port main body 10 forms a transparent band 70 in the circumferential direction of the cylindrical portion 10 ′ inserted into the needle-shaped main body 11, and the other policy-shaped main body 11 is inserted with the cylindrical portion 10 ′ of the port main body 10. The cylindrical portion 11 ′ has a circumferential transparent band 72. In portions other than the transparent bands 70 and 72, the port main body 10 and the needle-shaped main body 11 are subjected to printing, labeling, and graining (roughening) so as to be opaque. The transparent belts 70 and 72 are spaced apart and do not overlap in the normal state (when unopened (when the protrusion 20 is not broken)) shown in FIG. 10 (a), but the whole is not transparent, but when opened (when the protrusion 20 is broken) As shown in FIG. 10 (b), since the transparent bands 70 and 72 overlap each other, the whole can be seen through, and this is an indicator that a predetermined depth has been pushed.

図10の実施形態においてポート本体10の帯状領域70(今度は透明でなくてもよい)に適当な文字(例えば“開通”とか“Open”)を刻印しておくような変形実施形態も可能である。帯状部70, 72は図10(イ)に示す通常時(未開封時(突起20の未折損時))は離間し、重ならないためポート本体10の帯状領域70は上側に位置する不透明の針状本体11により遮蔽され、“開通”とか“Open”の文字は見えない。しかしながら、開封時(突起20の折損時)は図10(ロ)に示すように帯状部70, 72が重なるため、下側のポート本体10の帯状部70に刻印された“開通”とか“Open”の文字が上側の針状本体11の透明帯状部72より透けて視認できるため、これをもって所定深さの押し込みがなされたことの指標とすることができる。   In the embodiment of FIG. 10, a modified embodiment in which an appropriate character (for example, “open” or “Open”) is engraved on the band-like region 70 (which may not be transparent in this case) of the port body 10 is also possible. is there. The band-like portions 70 and 72 are separated in the normal state (when unopened (when the protrusion 20 is not broken)) shown in FIG. 10 (a) and do not overlap, so the band-like region 70 of the port body 10 is an opaque needle located on the upper side. It is shielded by the main body 11 and the characters “open” and “Open” cannot be seen. However, at the time of opening (when the protrusion 20 is broken), as shown in FIG. 10 (B), the band-like portions 70 and 72 overlap each other, so that “open” or “Open” stamped on the belt-like portion 70 of the lower port body 10 is provided. Since the character "" can be seen through the transparent belt-like portion 72 of the upper needle-like main body 11, it can be used as an indicator that a predetermined depth has been pushed.

図11は押込深さ確認手段の更に別実施形態を示しており、通常は開放されているが、開通時に閉鎖される識別部74をポート本体10に設けたものである。即ち、識別部74は閉鎖状態を表す文字(例えば“未開封”とか“Close”)などの記号やライン等であり、フランジ部28に近接して設けられ、図11(イ)に示す通常時(未開封時(突起20の未折損時))はフランジ部28が針状本体11の端面から離間しているため、識別部74が外部に露出され、“未開封”とか“Close”を作業員に視認せしめることができる。そして、開通時(突起20の折損時)は図11(ロ)に示すように識別部74の“未開封”とか“Close”といった文字やラインは不透明な針状本体11により閉鎖され視認不可となるため、これをもって所定深さの押し込みがなされたことの指標とすることができる。   FIG. 11 shows still another embodiment of the indentation depth confirmation means. The port main body 10 is provided with an identification portion 74 that is normally opened but is closed at the time of opening. That is, the identification part 74 is a symbol or a line such as a character indicating a closed state (for example, “unopened” or “Close”), and is provided in the vicinity of the flange part 28. (When not opened (when the protrusion 20 is not broken)), since the flange portion 28 is separated from the end surface of the needle-like main body 11, the identification portion 74 is exposed to the outside, and “unopened” or “Close” is operated. It can be visually recognized by employees. At the time of opening (when the protrusion 20 is broken), characters and lines such as “unopened” or “Close” of the identification portion 74 are closed by the opaque needle-like body 11 and cannot be visually recognized as shown in FIG. Therefore, it can be used as an indicator that a predetermined depth has been pushed.

図12は押込深さ確認手段の更に別実施形態を示し、この実施形態ではラインの一致・不一致により確認を行うものである。即ち、ポート本体10の周面上には第1の一致判別ライン76が刻印され、針状本体11には端面におけるスリット11Bを挟んで第2の一致判別ライン78が刻印される。図12(イ)に示す通常時(未開封時(突起20の未折損時))はライン76, 78は離間しているため未開通と判断できる。開封時(突起20の折損時)は図12(ロ)に示すようにライン76, 78は整列されるため、これをもって所定深さの押し込みがなされたことの容易・確実な判断指標とすることができる。   FIG. 12 shows still another embodiment of the indentation depth confirmation means. In this embodiment, confirmation is performed by line coincidence / non-coincidence. That is, the first coincidence determination line 76 is engraved on the peripheral surface of the port main body 10, and the second coincidence determination line 78 is imprinted on the needle-like main body 11 with the slit 11 </ b> B at the end face interposed therebetween. In the normal state (when unopened (when the protrusion 20 is not broken)) shown in FIG. When opened (when the protrusion 20 is broken), the lines 76 and 78 are aligned as shown in FIG. 12 (b), and this should be used as an easy and reliable indicator of the pushing of the predetermined depth. Can do.

Claims (3)

点滴バッグに軟質容器からの薬剤を移送するための薬剤移送具であって、軟質容器に連結され、軟質容器からの薬剤を受容すべき第1の筒状本体と第1の筒状本体から離間側に薬剤の排出のための針状部を形成した第2の筒状本体とを具備して成り、針状部は点滴バッグを封止する弾性材製の栓体の穿刺を行うものであり、前記第1の筒状本体は第2の筒状本体に対し相対摺動可能に挿入され、第1及び第2の筒状本体は摺動方向において対向する第1及び第2の端面を夫々形成しており、第1の筒状本体の前記第1の端面は第2の筒状本体の前記第2の端面に向けて片持状に突出する突起部を備え、かつこの突起部は前記第1の端面に対して脆弱部を介して連結されており、第2の筒状本体の第2の端面は第1の筒状本体の第1の端面における前記突起部を収容するための凹部を形成しており、更に、第1及び第2の筒状本体は摺動時における回転方向の位置決めのための位置決め手段を具備しており、軟質容器からの薬剤は通常は前記第1の筒状本体内において封止状態にあるが、第1及び第2の筒状本体の相対摺動により突起部が前記凹部に収容され、前記第1及び第2の端面の当接により第2の端面に当接する第1の端面の部位が少なくとも部分的に破損されて、第1の筒状本体における薬剤の前記封止状態が解除され、軟質容器の薬剤は前記針状部を介して点滴バッグ中の薬剤に混注のための薬剤の移送が可能となるようにされることを特徴とする薬剤移送具。 A drug transfer tool for transferring a drug from a soft container to an infusion bag, the first cylindrical body connected to the soft container and receiving the drug from the soft container, and a first cylindrical body And a second cylindrical main body formed with a needle-like portion for discharging the medicine on the separated side, and the needle-like portion punctures a plug made of an elastic material for sealing the drip bag. The first cylindrical body is inserted so as to be slidable relative to the second cylindrical body, and the first and second cylindrical bodies have first and second end faces opposed to each other in the sliding direction. The first end surface of the first cylindrical body is provided with a protrusion that projects in a cantilevered manner toward the second end surface of the second cylindrical body, and the protrusion is The second end surface of the second cylindrical main body is connected to the first end surface of the first cylindrical main body via a fragile portion. The first and second cylindrical bodies are provided with positioning means for positioning in the rotational direction during sliding, and are formed from a soft container. the drug usually is in sealed state in said first tubular body, projections Ri by the relative sliding movement of the first and second cylindrical body is accommodated in said recess, said first and The portion of the first end surface that contacts the second end surface is at least partially damaged by the contact of the second end surface, and the sealed state of the medicine in the first cylindrical body is released, and the soft container A medicine transporting device, wherein the medicine can be transported to the medicine in the infusion bag via the needle-like portion for mixed injection. 請求項に記載の発明において、第1の筒状本体と第2の筒状本体との摺動抵抗は前記針状部による前記栓体の穿刺抵抗より大きいことを特徴とする薬剤移送具。2. The drug delivery device according to claim 1 , wherein a sliding resistance between the first cylindrical main body and the second cylindrical main body is larger than a puncture resistance of the plug body by the needle-like portion. 請求項に記載の発明において、折損による封止状態の解除に至るまでの第1及び第2の筒状本体間の相対摺動操作の完了を確認せしめるための確認手段を更に具備したことを特徴とする薬剤移送具。The invention according to claim 1 further comprises confirmation means for confirming completion of the relative sliding operation between the first and second cylindrical bodies until the sealed state is released due to breakage. A drug delivery device.
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EP1859773A4 (en) 2012-02-22
US20080097372A1 (en) 2008-04-24
EP1859773B1 (en) 2013-04-24
US7896860B2 (en) 2011-03-01
JPWO2006098345A1 (en) 2008-08-21
EP1859773A1 (en) 2007-11-28

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